[Congressional Record Volume 140, Number 84 (Tuesday, June 28, 1994)]
[Senate]
[Page S]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]
[Congressional Record: June 28, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]
CLOTURE MOTION
The PRESIDING OFFICER. The hour of 6 p.m. having arrived, under the
previous order, the clerk will report the motion to invoke cloture.
The assistant legislative clerk read as follows:
Cloture Motion
We, the undersigned Senators, in accordance with the
provisions of rule XXII of the Standing Rules of the Senate,
hereby move to bring to a close the debate on Calendar No.
409, S. 687, a bill to regulate interstate commerce by
providing for a uniform product liability law:
Jay Rockefeller, J. Lieberman, John Glenn, Claiborne
Pell, Bob Kerrey, J.J. Exon, Harlan Mathews, Slade
Gorton, Orrin G. Hatch, Strom Thurmond, Daniel Coats,
Judd Gregg, Dirk Kempthorne, Pete V. Domenici, Larry
Pressler, Kay Bailey Hutchison, Frank H. Murkowski.
vote
The PRESIDING OFFICER. By unanimous consent, the quorum call has been
waived.
The question is, Is it the sense of the Senate that the debate on S.
687, the product liability fairness bill, shall be brought to a close?
The yeas and nays are automatic under the rule, and the clerk will
call the roll.
The legislative clerk called the roll.
Mr. METZENBAUM. Mr. President, on this vote I have a pair with the
distinguished Senator from Arizona [Mr. DeConcini]. If he were present
and voting, he would vote ``yea.'' If I were at liberty to vote, I
would vote ``nay.'' Therefore, I withhold my vote.
Mr. FORD. I announce that on this vote, the Senator from Arizona [Mr.
DeConcini] is paired with the Senator from Ohio [Mr. Metzenbaum].
If present and voting, the Senator from Arizona would vote ``aye''
and the Senator from Ohio would vote ``nay.''
The PRESIDING OFFICER (Mr. Mathews). Are there any other Senators in
the Chamber who desire to vote?
The yeas and nays resulted--yeas 54, nays 44, as follows:
[Rollcall Vote No. 169 Leg.]
YEAS--54
Bennett
Bond
Boren
Brown
Burns
Byrd
Chafee
Coats
Coverdell
Craig
Danforth
Daschle
Dodd
Dole
Domenici
Durenberger
Exon
Faircloth
Glenn
Gorton
Gramm
Grassley
Gregg
Hatch
Hatfield
Helms
Hutchison
Jeffords
Kassebaum
Kempthorne
Kohl
Lieberman
Lott
Lugar
Mack
Mathews
McCain
McConnell
Mikulski
Murkowski
Nickles
Nunn
Packwood
Pell
Pressler
Pryor
Riegle
Robb
Rockefeller
Sasser
Smith
Stevens
Wallop
Warner
NAYS--44
Akaka
Baucus
Biden
Bingaman
Boxer
Bradley
Breaux
Bryan
Bumpers
Campbell
Cochran
Cohen
Conrad
D'Amato
Dorgan
Feingold
Feinstein
Ford
Graham
Harkin
Heflin
Hollings
Inouye
Johnston
Kennedy
Kerrey
Kerry
Lautenberg
Leahy
Levin
Mitchell
Moseley-Braun
Moynihan
Murray
Reid
Roth
Sarbanes
Shelby
Simon
Simpson
Specter
Thurmond
Wellstone
Wofford
PRESENT AND GIVING A LIVE PAIR, AS PREVIOUSLY RECORDED--1
Metzenbaum
NOT VOTING--1
DeConcini
The PRESIDING OFFICER. On this vote, the yeas are 54, the nays are
44. Three-fifths of the Senators duly chosen and sworn not having votes
in the affirmative the motion is rejected.
The majority leader.
Mr. MITCHELL. Mr. President, I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. WOFFORD addressed the Chair.
Mr. FORD. Mr. President, I will have to object to taking off the
quorum call.
The PRESIDING OFFICER. Objection is noted. The clerk will call the
roll.
Mr. FORD. I apologize.
The legislative clerk continued with the call of the roll.
Mr. MITCHELL. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
amenndment no. 1930
Mr. CHAFEE. Mr. President, I am intrigued by the amendment offered by
the Senator from Wisconsin, but I will not be supporting his amendment
today.
I am hesitant for Congress to move forward with this amendment for
two reasons. As my colleagues know, there already is in place a process
by which the rules may be changed; and this process involves a
recommendation by the U.S. Judicial Conference, and approval by the
U.S. Supreme Court. This process is in place because we have decided
that we should give due deference to the Conference to determine how
best the courts may serve the American public.
Now, Congress may certainly go ahead and propose changes absent a
recommendation from the Conference. But I would note also that in this
matter, even the administration has asked us to hold off until they
have determined what they view as the best course of action.
Thus, in the absence of a clear recommendation from either the
Judicial Conference or the administration, both of which could and
should provide some guidance on this matter, I am not comfortable
moving forward with this amendment.
I do feel, however, that this is an issue that needs to be pursued,
and I hope the Judicial Conference and the administration will move
expeditiously to come up with appropriate recommendations. This is not
a matter that should be delayed.
disastrous effects of product liability reform
Mr. GRAHAM. Mr. President, today, I met Ms. Marlo Mahne, a Floridian
whose story speaks volumes about the reasons the product liability bill
we are considering today should be defeated.
Ms. Mahne was horribly burned in a 1985 automobile accident in Fort
Pierce, FL. She was able to reach a settlement with the manufacturer of
the car in which she was a passenger. If S. 687 had been law in 1985,
the settlement she reached would never have been possible, Ms. Mahne
says. Further, if it is enacted now, it will prevent people who suffer
similar tragedies in the future from recovering the damages to which
they are entitled.
Mr. President, I have a statement here by Marlo Mahne which describes
her experience in her own words. I ask that it be included in the
Record and offer it as another of the many reasons this unwise
legislation should be rejected by the Senate.
There being no objection, the letter was ordered to be printed in the
Record, as follows:
Statement of Marlo Mahne, June 27, 1994
My name is Marlo Mahne. In 1985, when I was fifteen years
old, the 1967 Ford Mustang in which I was a passenger was
struck from behind. This is the same car that President
Clinton owns and drives. Because the fuel tank in the Mustang
was defective, it ruptured and the car burst into flames.
I had 3rd and 4th degree burns over 70 percent of my body.
Nearly all of my scalp was burned off. My ears and fingers
were burned off. My lips and nose have been reconstructed. I
am blind in one eye.
My initial stay in the hospital lasted 4 months, and I was
in and out over the next 18 months. Altogether I have had 118
major plastic surgeries and procedures, and I could have 20
or 30 more.
I sued the Ford Motor Company, and in 1991 my case was
settled out of court. Before then Ford did everything to
avoid the blame for what happened to me. Fortunately at the
time, Ford didn't have S. 687 to hide behind.
Ford said the underinsured driver of the Mustang and the
uninsured driver of the bullet car were at fault and should
bear equal responsibility. But those people didn't design a
defective fuel tank, ignore the defect, and put it on the
road.
You have in your packet an excerpt from the deposition of
Harold MacDonald, who was the vice president of Ford's
engineering research. Mr. MacDonald acknowledged that the
Mustang's fuel tank repeatedly ruptured in Ford's own tests,
but Ford did not act to correct the defect.
If it weren't for Ford, I might have walked away from the
crash. Instead, I will be a dependent person probably for the
rest of my life. The only thing that prevents me from being a
burden to taxpayers is the settlement I finally secured from
Ford. Now, because of S. 687, that is at risk for future
victims of defective products.
Although I am prohibited by a secrecy order from discussing
the settlement of my case and some of the details, I can tell
you that if Senate Bill 687 had been the law, it would have
shielded Ford from full responsibility for what the company
did to me.
Economic damages for me were modest at the time of the
crash because I was too young to work and my medical bills
were paid by the Shriners. The non-economic damages I sought
would have been greatly reduced if S. 687 had been the law
because there were three possible defendants: two drivers and
Ford.
Under S. 687, even though I would not have been burned if
the gas tank wasn't defective, Ford could claim it was
responsible for only one-third of my non-economic damages,
such as pain and suffering, which for me has been everything.
I don't think this is fair.
I am not an attorney, but as you might imagine, I've
learned a lot about the law since I was burned by Ford. I
thank God that I was able to have my case heard and that the
law today isn't designed to save money for manufacturers but
rather to pay for the harm caused the consumer. S. 687 would
take all that away from someone like me.
Mr. DURENBERGER. Mr. President, I rise today in strong support of the
Product Liability Fairness Act. I would like to thank my colleagues
Senators Rockefeller, Lieberman, Dodd, Gorton, and Danforth for their
leadership in bringing this legislation to the floor. I am proud to
join them in cosponsoring this important legislation.
I believe strongly that S. 687 will bring both cost-savings and
consumer safety to our current product liability system--fairly and
effectively.
S. 687 will reduce costs to consumers, stimulate product innovation,
promote U.S. competitiveness and, at the same time, ensure that
consumers have access to more safe and effective products.
A National Problem In Need Of A National Solution
Our Nation's product liability system is broken. It is badly broken,
and it is a problem which calls for us to respond with a national
solution. The current system does not fairly protect the injured,
stifles the development of innovative products, and harms U.S.
competitiveness.
About 70 percent of manufactured products are sold outside the State
in which they are made. The current patchwork system of State-by-State
product liability legislation poses a burden to interstate commerce and
encourages forum shopping.
In fact, the National Governors' Association [NGA] has continually
urged Congress to enact uniform product liability law. In a letter last
year to President Clinton, the NGA wrote: ``Clearly, a national product
liability code would greatly enhance the effectiveness of interstate
commerce.''
s. 687 will make product liability laws more fair to injured consumers
Several recent studies have found that people who are severely
injured by products are compensated for only a small fraction of their
economic losses. Those studies found that claimants' recoveries for
losses exceeding $1 million are less than 39 percent. In contrast,
those with minor injuries recover a windfall of nearly five times their
losses.
A 1989 GAO study found that product cases take about 3 years to
resolve, and even longer if there is an appeal. Because larger claims
generally take longer to resolve than small claims, severely injured
victims must wait years to receive compensation. These delays force
those who are most severely injured to settle for inadequate amounts.
Moreover, the cost of bringing a product liability lawsuit is
outrageously high. A 1986 study by the Rand Institute for Civil Justice
found that the annual transaction costs of the tort system exceed the
compensation awarded to injured persons. A 1993 survey by the
Association of Manufacturing Technology found that the lion's share of
the costs associated with defending a product liability lawsuit go to
attorneys' fees, subrogation, and court costs. Less than one-quarter of
the total transaction costs associated with a product liability defense
actually go to the injured party. This is clearly unacceptable.
the product liability system imposes excessive costs which are harmful
to u.s. competitiveness
Excessive product liability costs have resulted in significant market
share loss for some U.S. companies. The U.S. machine tool industry, for
example, has lost more than 20 percent of its domestic market share to
foreign competitors whose liability costs are lower and far more
predictable.
Jobs have been lost in the United States as companies shift
production abroad to take advantage of less stringent product liability
laws. Innovative products made and marketed abroad are lost to U.S.
consumers.
The fear of product liability has also diminished investment in basic
scientific research. Malcolm Skolnick, a lawyer and professor of
biophysics at the University of Texas testified before the Commerce
Committee that:
Scientific inquiry is stifled. Ideas in areas where
litigation has occurred will not receive support for
exploration and development. Producers fearful of possible
suits will discourage additional investigation which can be
used against them in future claims.
the product liability system discourages innovation and advancements in
medical products
Perhaps the most critical reason I became involved in this issue is
that the excessive costs of the current product liability system harm
consumers and patients by discouraging innovation and development of
lifesaving and cost-saving medical products.
Jim Vincent, chairman and CEO of Biogen, told the Senate Commerce
Committee that he has decided not to pursue research into the
development of an AIDS vaccine because of the current product liability
system. One company that is attempting to develop an AIDS vaccine told
the Commerce Committee that it was forced to delay important clinical
trials because of liability concerns.
The research supports this anecdotal evidence. The Office of
Technology Assessment found that the fear of potential liability is a
serious barrier to research, testing, and marketing of vaccines. OTA
recommends action by the Federal Government.
Excessive product liability costs have also forced manufacturers to
withdraw even successful products from the market. For example, in
1983, Merrell Dow withdrew Benediction, an anti-nausea drug for
pregnant women, because the cost of litigation arising out of use of
the drug far exceeded revenue. The FDA and the health care
professionals believe the product is safe; yet there is no comparable
drug on the market. This, too, is unacceptable. Americans want new and
better products that will improve their lives. They do not want to
travel to other countries to illegally obtain drugs not approved in the
United States, yet that happens on a regular basis. Part of this
problem relates to the slow FDA approval process, but product liability
weights heavily here as well.
biomaterials shortage threatens access to medical products
Mr. President, I also want to speak briefly on behalf of the
amendment that will be offered by my colleague from Connecticut and is
based on a bill we introduced last week: the Biomaterials Access
Assurance Act of 1994.
This amendment, in my opinion, represents a significant step forward
in reducing the costs of medical devices. It would reform our product
liability laws to assure raw material suppliers that they will not be
held liable unless there is real evidence that they were responsible
for the product defect.
Our current product liability system makes it much too easy to bring
lawsuits against raw materials suppliers, and too costly for those
suppliers to defend themselves even when they ultimately win. Unless we
include protections for raw material suppliers in this legislation,
those who make many of the lifesaving medical devices that we take for
granted today may no longer be able to purchase the raw materials and
components necessary to produce their products.
Notwithstanding the fact that raw materials and component parts
suppliers do not design, produce or test medical implants and devices,
they have been sued in cases alleging inadequate design and testing of
permanently implanted medical devices, testing of those devices, and
warnings related to those devices. And even though these suppliers have
almost never been held liable in these lawsuits, the cost of litigation
far exceeds the total potential sales of raw materials and component
parts to the medical device industry. As a result, many suppliers have
simply stopped supplying raw materials and component parts to medical
device manufacturers.
We in Congress must not allow the 7.4 million people who literally
owe their lives and the quality of their lives to medical devices--and
the countless others who will depend on medical devices in the years to
come--to become casualties of our outmoded product liability system.
I urge the support of my colleagues for the Lieberman-Durenberger
amendment.
fda provision
Mr. President, concerns have been raised by some of my colleagues in
recent days about section 203(b) of this bill, which provides that
manufacturers of drugs or medical devices that have been approved by
the Food and Drug Administration [FDA] shall not generally be subject
to punitive damages in product liability litigation.
In my view, Mr. President, it is unfortunate that this provision has
drawn such negative responses. I believe that section 203(b) is the
most important provision of the Product Liability Fairness Act. And I
strongly urge my colleagues: If we are ever going to be able to get a
handle on runaway health care costs, we must reject attempts to strike
this provision from the bill before us today.
I believe that a good deal of my colleagues' skepticism is due to a
fundamental misunderstanding of the FDA's approval process and of the
provisions of this bill.
First of all, it is important to point out that this provision
applies only to punitive damages. Plaintiffs harmed by an FDA-approved
drug or medical device will still be able to get the full range of
compensatory damages, including all past and future out-of-pocket
expenses such as medical bills, rehabilitation costs, lost wages,
diminished earning capacity, costs of providing household or child care
services. S. 687 also places no limits on noneconomic damages such as
pain and suffering or loss of companionship.
Second, the FDA approval process is extremely rigorous, and involves
very difficult scientific judgments. The FDA does not take its role in
approving drugs and devices lightly. In fact, the average length of
approval for new drugs is 9 years, which, in my judgment, is far too
long and in itself stifles innovation.
Moreover, section 203(b) applies only to those manufacturers who have
complied fully with the FDA requirements after a product is approved.
And, it does not apply if FDA approval was achieved as a result of
bribery or if any relevant information required to be submitted was
withheld from the FDA.
Finally, Mr. President, I would like to address several misstatements
of fact that have been made over the last few weeks.
Some have said that products such as Dalkon shield, DES, and silicone
gel breast implants, demonstrate that this provision will shield
manufacturers of dangerous products from legal liability. The fact,
however, is that none of these products has ever been approved by the
FDA as safe and effective. Under S. 687, only those products that have
been approved by FDA qualify for protection.
Opponents of this measure also argue that it will allow manufacturers
to get away with putting unsafe products on the market. However,
manufacturers will continue to have strong incentives to put safe
products on the market because they will be fully liable for all harm--
and compensatory damages alone can bankrupt a company.
conclusion
Mr. President, it is not often that I find myself in total agreement
with my colleagues Senator Rockefeller, Senator Dodd, and Senator Pell,
as well as Senator Gramm, Senator Helms, and Senator Faircloth on any
one issue. I am grateful particularly to the persistence of Senator
Rockefeller to pursue this legislation as aggressively as he has. This
legislation should not be controversial, yet it is perceived to be a
threat by those lawyers who greatly benefit from successful law suits
including large punitive damages. Our goal here today should be to
protect Americans who suffer from use of defective products as well as
to provide new and better choices for our citizens. This bill meets
those goals.
There is broad bipartisan support which exists across the entire
political perspective on this issue. The legislation is carefully
balanced and deserves our support.
At this point, I would like to submit for the Record a description of
the FDA's reporting requirements for drugs and medical devices.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Food and Drug Administration [FDA]--Federal Report Requirements on
Drugs and Medical Devices
drugs (21 cfr 314.80)
Manufacturers are required to keep records relating to
production methods for a drug and its safety and
effectiveness once a new drug is approved. In general,
companies must report to FDA every 3 months during the first
year, every 6 months during the second year, and once a year
after the first two years.
All serious and unexpected adverse drug experiences must be
reported to FDA within 15 working days under the title of a
15-day Alert Report. Adverse drug experiences that are not
both serious and unexpected need only be reported at
quarterly intervals for the first three years, and then
annually.
The company shall maintain, for a period of ten years,
records of all adverse drug experiences including raw data
and any correspondence relating to adverse experiences.
All adverse reaction reports are available under Freedom of
Information Act (FOIA) requests.
medical devices (21 cfr 803)
FDA requires device manufacturers or importers to report to
FDA whenever the manufacturer or importer receives or
otherwise becomes aware of any information that reasonably
suggests that one of its marketed devices:
(1) may have caused or contributed to a death or serious
injury; or
(2) have malfunctioned and that the device or any other
device marketed by the manufacturer or importer would be
likely to cause or contribute to a death or serious injury if
the malfunction were to occur.
Report requirements by manufacturers (21 CFR 803.24)
Manufacturers and importers must submit such reports to the
FDA whenever they receive or otherwise become aware of any
information: oral or written; in a medical or scientific
literature, published or unpublished; or through a
manufacturer's own research, testing evaluation, serving or
maintenance of one of its devices.
Such reports must be made by telephone as soon as possible,
but no later than within 5 calendar days of the initial
receipt of information, and followed by a written report to
FDA within 15 working days of the initial receipt of
information.
Public availability of reports (21 CFR 803.9)
Any report, including any FDA record of a telephone report,
submitted under the provisions is available for public
disclosure.
Recordkeeping requirements (21 CFR 803.31)
Manufacturers are required to keep records for the life of
the device or two years, whichever is greater.
Order of Procedure
Mr. MITCHELL. Mr. President, following the vote on cloture, I
convened a meeting in my office of several Senators who are involved
directly in this matter, both proponents and opponents of the
legislation, and we discussed the best way in which to proceed.
Following that discussion I made a decision which I will now announce
and which I believe all of the Senators involved concur in.
Following my remarks, Senator Gorton will be recognized to withdraw
his amendment.
Following that, Senator Dorgan will be recognized to offer an
amendment. That will be the pending amendment. And there will be no
vote on that amendment prior to the cloture vote, which will occur at
10 a.m. tomorrow. So, therefore, I can now announce there will be no
further rollcall votes this evening. Both staffs may notify Senators of
that fact. The next vote will be the cloture vote at 10 o'clock
tomorrow morning and then, depending upon the outcome of that vote--how
we proceed thereafter will be dependent upon the outcome of that vote.
There will be debate this evening on the Dorgan amendment, after it
is offered, for so long as Senators wish to address that subject. But
there will be no recorded votes.
I would like to now, before we proceed--I am going to ask Senators
Gorton and Rockefeller, and Senator Heflin, if I may have the attention
of the Senator from Alabama--I will ask Senators if I have correctly
stated the understanding which we have just reached with respect to our
present proceeding?
Mr. GORTON. You have.
Mr. HEFLIN. I understand there will be no votes, even on the Dorgan/
Moseley-Braun amendment, before the cloture vote. The next vote will be
cloture?
Mr. MITCHELL. That is correct.
Mr. ROCKEFELLER. Will the majority leader yield? Will this
arrangement contemplate an hour of discussion prior to the 10 o'clock
cloture vote?
Mr. MITCHELL. Under the rules there would ordinarily be a cloture
vote 1 hour after the Senate convenes. We have now set the cloture
vote, by unanimous consent, and I inquire of the parties--I will
inquire of Senator Rockefeller and Senator Heflin, and Senator
Hollings, whether they wish to have that further debate tomorrow
morning or whatever time is convenient for my colleagues?
Mr. ROCKEFELLER. The Senator would prefer it.
Mr. HEFLIN. We would have no objection, after morning business.
Mr. MITCHELL. I ask the staff, in preparing for the close of business
this evening, that the order be prepared in such a way that the Senate
will come into session--at least return to this matter at 9 a.m., and
have a vote at 10 a.m., and that hour will be equally divided in the
usual form between the two sides, under the control of Senator
Rockefeller in favor, the proponents, and Senator Heflin will control
the time in behalf of the opponents. Senator Rockefeller or his
designee or Senator Heflin or his designee will control the time.
Mr. LAUTENBERG. Will the majority leader yield?
Mr. MITCHELL. Yes.
Mr. LAUTENBERG. I am sorry I missed some part of the discussion. Is
it the intention to stay in session now and deal with the bill?
Mr. MITCHELL. For debate only. Senator Gorton is going to withdraw
his amendment. Senator Dorgan is going to offer an amendment and that
will be the subject of debate only. The next vote will be on cloture at
10 a.m. tomorrow.
Mr. LAUTENBERG. Is it the intent of the managers to permit amendments
beyond that which have been discussed to be offered this evening?
Mr. MITCHELL. The opponents have indicated they will not permit a
vote on the Dorgan amendment. No discussion occurred with other
possible amendments. That would, of course, require Senator Dorgan's
amendment be set aside. And that would require unanimous consent,
including his. There was no discussion of that in our meeting. I expect
the Senator from New Jersey, if he wants to do that, would have to
inquire of the Senators involved.
Mr. LAUTENBERG. I thank the majority leader.
Mr. MITCHELL. Mr. President, if it is agreeable then--and I take the
remarks of the Senators to indicate that it is agreeable--I repeat,
there will be no further rollcall votes this evening. The next rollcall
vote will be at 10 a.m. tomorrow on cloture on the bill.
I thank my colleagues for that cooperation and I yield the floor.
amendment no. 1941
Mrs. KASSEBAUM. Mr. President, I was wondering if the distinguished
Senator from Connecticut might be willing to answer a few questions
with respect to the impact of S. 687 on suits against manufacturers of
drugs and medical devices. While many of these points have been
mentioned in this debate, I would appreciate further clarification.
First, as I understand it, the statute of limitations provisions of
S. 687 will ensure that individuals who may be exposed to a harmful
product will not lose their right to sue before they reasonably could
have known both that they were injured and that the product may have
caused their harm. This in essence means that in a number of States, S.
687 will make it easier, not harder to sue drug and medical device
companies.
Mr. LIEBERMAN. The Senator from Kansas is correct. Section 204
provides a uniform statute of limitations of 2 years from the date a
claimant knew or should have known both of the injury and its cause. It
will have exactly the effect you outlined.
Mrs. KASSEBAUM. There have been many accusations that the so-called
FDA provisions of this bill would prevent persons who are injured by
FDA approved drugs and medical devices from seeking compensation from
manufacturers. As I read section 203(b), however, it applies only to
claims for punitive damages, not to claims for compensatory damages, so
that claimants will still be able to sue under State law for any
compensatory damages, just as they do now.
Mr. ROCKEFELLER. Again the Senator from Kansas is correct. Section
203(b) has no impact on claims for compensatory damages such as lost
wages, medical costs, costs of replacement services or pain and
suffering.
Mrs. KASSEBAUM. I know the Senator has said this before, but it is my
understanding from reviewing this legislation that the so-called FDA
provision does not cover DES, Dalkon Shields, silicone gel breast
implants, or super-absorbency tampons. Am I correct?
Mr. LIEBERMAN. The Senator is correct. Section 203(b) only provides
``good actor'' protection against punitive damages if the product is
subject to pre-market approval by the FDA and is actually approved.
Pre-market approval is a very specific concept under our food and drug
laws. As the Senator, the ranking member of the Committee on Labor and
Human Resources, knows, when DES was first marketed and prior to 1962,
new drugs could be placed on the market without any formal action by
FDA. At that time, all a company had to do was file information with
FDA indicating that a product was safe, and if FDA did not respond
within 60 days, the manufacturer could go ahead and market it. This
type of system is pre-market notification, not pre-market approval. A
drug could also be placed on the market at that time if it was
``generally recognized as safe.''
In 1962, Congress changed the drug laws completely. After 1962, new
drugs could not be placed on the market until FDA actually approved the
new drug application, unless the drug was found to be ``generally
recognized as safe and effective.'' These are the two tests we use in
section 203(b) with respect to drugs: was the drug actually approved
under a new drug application, or was it generally recognized as safe
and effective. DES was never generally recognized as safe and
effective, and it was never actually approved under a post-1962 drug
application. Thus, DES is not covered under section 203(b).
A similar analysis applies with respect to Dalkon Shields and breast
implants. Both of those products were placed on the market prior to
enactment of the Medical Devices Amendments of 1976. Dalkon Shields
were marketed entirely prior to 1976, so they could never have received
FDA approval. Silicone gel breast implants were grandfathered because
they were already on the market in 1976. Grandfathered devices did not
need to receive pre-market approval. Thus, neither Dalkon Shields nor
silicone gel breast implants are covered by the FDA/punitive damages
provisions.
Super absorbency tampons are class II medical devices, and hence are
not subject to pre-market approval by FDA. Thus, they are not covered
by section 203(b) either.
Mrs. KASSEBAUM. I notice that a number of the ``horror stories''
cited by opponents of S. 687 are cases in which claimants regularly
assert that the manufacturer failed to submit required information to
the FDA. One such case involved a copper-7 IUD. In another recently
publicized case, a manufacturer of cardiac catheters, C.R. Bard, was
found to have engaged in criminal withholding of information from the
FDA. As I read S. 687, it provides no punitive damages protection for
manufacturers who have failed to abide by their FDA duties and who have
been sued because of a resulting injury.
Mr. LIEBERMAN. The Senator is again correct. In every ``horror
story'' of which I am aware, claimants have alleged that the
manufacturer did not supply required information to the FDA.
Mrs. KASSEBAUM. I have one other question. Opponents of this
legislation have been claiming that the provision making liability for
noneconomic losses several rather than joint hurts women because they
cannot recover fully for reproductive injuries in drug and medical
device cases. From what I am told, however, joint liability is rarely
an issue in drug and medical device cases. Before joint liability can
be an issue, there must be two people who helped cause the harm. In
drug and device cases, however, the only party that caused the harm is
the manufacturer. Thus, joint liability cannot be an issue in those
cases.
Mr. LIEBERMAN. Again the Senator is correct. Joint liability is
simply not an issue in most drug and medical device cases.
Interestingly enough, in DES and other market share liability cases, in
which there are often several defendants, courts have refused to make
liability joint. Courts have viewed joint liability as inconsistent
with market share liability.
Mrs. KASSEBAUM. Based on what I know about the provisions of S. 687
governing punitive damages for FDA approved products and several
liability for noneconomic harm, I simply do not believe that S. 687 is
antiwoman. In fact, passage of S. 687 could substantially help women.
The Institute of Medicine has recommended enactment of an FDA
compliance defense as a means of lowering one of the significant
barriers to the development of new contraceptives. By encouraging
research, development and innovation in the health field, S. 687 could
help to spur the development of products to diagnose and treat
osteoporosis, breast cancer, and cervical cancer.
I believe the provisions of S. 687 granting ``good actor'' protection
against punitive damages to manufacturers who comply fully with FDA
requirements will have an extremely positive effect on the public
health. I urge my colleagues not to strike section 203(b), and to vote
to support cloture on this bill.
The PRESIDING OFFICER. The Senator from Washington is recognized.
Mr. GORTON. Mr. President, I withdraw the first-degree amendment.
The PRESIDING OFFICER. The Senator has that right. The amendment is
withdrawn.
So the amendment (No. 1941) was withdrawn.
Mr. DORGAN addressed the Chair.
The PRESIDING OFFICER. The Senator from North Dakota.
Amendment No. 1895
(Purpose: To eliminate provisions limiting punitive damages concerning
certain drugs and medical devices and certain aircraft and components)
Mr. DORGAN. Mr. President, I send an amendment to the desk. It is
amendment No. 1895. The amendment is offered on behalf of myself,
Senator Moseley-Braun, Senator Mikulski, Senator Riegle, and Senator
Feinstein.
The PRESIDING OFFICER. The clerk will report amendment No. 1895.
The legislative clerk read as follows:
The Senator from North Dakota [Mr. Dorgan], for himself,
Ms. Moseley-Braun, Ms. Mikulski, Mr. Riegle, and Mrs.
Feinstein, proposes an amendment numbered 1895.
The amendment is as follows:
On page 19, beginning with line 7, strike out all through
line 6 on page 22.
Mr. DORGAN. Mr. President, I will be brief, and then I would like to
call on my colleague, Senator Moseley-Braun, who has worked with me in
recent weeks in preparing this amendment. This is a very short
amendment and a very simple amendment. It is substantial in its
consequences but, nonetheless, simple.
It simply strips from this bill that the Senate is now considering
the provision, section 203, that establishes a test for manufacturers
with respect to punitive damage awards and FDA and PAA approval. And
that test is that if the FDA or FAA has approved their products, then
there is developed a shield behind which it is much more difficult to
seek punitive damages from the manufacturer. In other words, it
establishes a protection for manufacturers if the Federal agency, in
this case the FDA or FAA, has approved the product.
I have said before--I will be very brief now because I spoke
earlier--I said it is legion to review the products that have been
approved in good faith by the FDA that later proved to be very
troublesome products: The Dalkon shield, DES, silicon breast implants,
and a range of areas. I have gone through a list of drugs and medical
devices. I will not repeat them.
But it is clear that the FDA has not been capable, nor should we
expect it to be capable, of approving a range of drugs and a range of
medical devices, to say that we have the staff, we have the capability,
we have the investigative power--of saying when we approve this, we
understand it does no harm and we represent that to be the case and we
will construct from that a shield to protect manufacturers against
punitive damages.
The Senator from Illinois, Senator Moseley-Braun, and I feel strongly
that this is a terrible provision in this bill and it must be
eliminated.
If we eliminate this provision in this bill, I said on the floor
previously and I will say again that I will support this piece of
legislation. But this provision in this bill is very troublesome and,
in my judgment, should not advance.
Mr. GORTON. Will the Senator from North Dakota yield for just a
moment?
Mr. DORGAN. I will be happy to yield to the Senator from Washington.
Mr. GORTON. Mr. President, as the Senator from North Dakota well
knows, this Senator, as one of the primary sponsors of the bill,
disagrees with his friend's characterization of the FDA defense against
punitive damages under certain circumstances and has spoken vehemently
over an extended period of time in favor of just that provision.
As this Senator has assured his friend from North Dakota privately,
in order to get a bill through with which the Senator from North Dakota
and the Senator from Washington agree, leaving this portion of it
aside, this Senator is, in fact, going to vote in favor of the
amendment proposed by the Senators from North Dakota and Illinois and
will undertake to persuade as many of his colleagues on this side of
the aisle to follow his lead as is possible; that he feels a very large
number of them, or a very substantial number of them will do so.
The Senator from Washington makes that assurance because it is quite
evident now that opponents to the bill will prevent the amendment
proposed by the Senator from North Dakota from coming for a vote before
tomorrow's cloture vote. But I simply want the two Senators who are
sponsoring this amendment to know that whatever my view on the merits,
I will vote with them and I will undertake to secure a sufficient
number of votes from this side to assure, as much as can ever be
assured, that they will, in fact, be victorious.
Mr. DORGAN. Mr. President, I appreciate the Senator's comments. It
has been some months since we marked this bill up in the Commerce
Committee and moved it forward. During those months, Senator Moseley-
Braun and I have worked on this issue because we have felt very
concerned about this.
This is a sea change of sorts, when he says he will support this
amendment. Our dilemma at the moment, of course, is we are told we may
not get a vote on this amendment prior to the next cloture vote, and we
will have to talk some about that. I hope that is not the case, but
some suggest they do not want to vote on this and will continue talking
about it.
Having gone through this a few minutes ago, let me at this point
suspend; and my colleague from Illinois, Senator Moseley-Braun, I
think, can state this better than can I. Let me yield the floor, Mr.
President, so that my colleague, who has worked very hard on this over
the last months, may speak to it.
Mr. President, I yield the floor.
The PRESIDING OFFICER. The Senator from Illinois.
Ms. MOSELEY-BRAUN. Mr. President, there is an old expression that
says that those who love the law or sausages should not watch either of
them being made. I daresay that is the situation with which we are
confronted with regard to the pending amendment and with regard to
produce liability reform in general.
Let me say at the outset, Mr. President, that I have voted against
cloture primarily because I was concerned about problems with this
legislation and convinced that the problems in this legislation,
particularly the problems related to the FDA and FAA excuse, did not
overcome the merits of the legislation.
The merits of the legislation include the fact that I believe we
really do need to have some national standards in the area of product
liability. Without rational standards, people are sent pillar to post
to defend actions with different standards and different rules. I do
believe that there has been abuse with the operation of our tort law in
this country.
That argument has been raised by manufacturers who say that shipping
their products is made more expensive by operation of the tort laws in
our country. And there has been a great deal of discussion about the
larger impact that product liability laws have on the competitiveness
and stability of businesses in this country.
What Senator Dorgan and I have specifically tried to address is one
narrow portion of this bill, in an effort to make the legislation a
better bill, in an effort to address the specific issues that concern
the rights of victims, of little people, who may not be heard
otherwise. While the battle over product liability law is largely a
battle of the network giants, a battle of big-picture issues and huge
interests, Senator Dorgan and I have tried to take steps to protect the
forgotten consumer.
The pending amendment relates specifically to the health and safety
of those who may be injured by defective drugs and medical devices that
are approved by the FDA or by aircraft components approved by the FAA.
S. 687 provides what we call the FDA excuse. I know the Senator from
Washington disagrees with my characterization. But essentially what it
says is that a person cannot get punitive damages for a defective
medical device, such as an IUD or silicon breast implant; or a
defective medical drug, so long as that device or drug had received
premarket approval from the FDA, so long as the FDA said the device was
OK. That turns tort law, as we have always known it, on its head, and
establishes an administrative agency as a gatekeeper to decide what
damages might otherwise be allowed in the law.
We know from experience that FDA is understaffed, overworked, and
does not have the capacity to do the kind of analysis, to do the kind
of research, to actually guarantee that the public will not be
subjected to unreasonably dangerous drugs or medical devices.
So this FDA excuse will have the effect of shifting responsibility
from the manufacturers of the defective products to the Government.
That struck Senator Dorgan and me as being inappropriate; that this
shifting of responsibility was not what S. 687 intended to do and that
it was not what the proponents of this legislation wanted to do; and
that it was entirely inappropriate, in fact, to place with an
administrative agency in this level of control over the rights of
victims of defective medical devices and products.
Happily, I think, the managers of this legislation have agreed with
Senator Dorgan and me with regard to the FDA excuse. They have agreed
that our amendment, which simply strikes those portions of the bill
relating to the FDA and FAA excuse, should be adopted.
So the whole section of the bill relating to what we call the FDA
excuse would be stricken, taken out of the bill, by virtue of this
amendment.
I would like to add, having worked on the amendment for a number of
months now, Senator Dorgan and I have now been joined by three
additional cosponsors--Senators Reigle, Mikulski, and Feinstein--
because it really is a good idea. It is a good idea for protecting
people, and by that I mean the ordinary people, not the big money
interests, not the big giants, but the folks who actually might suffer
an injury from an FDA or FAA approved product.
Well, that may sound straightforward, Madam President, but the
problem is that our amendment addresses the merits and not the
procedure. And so here we are in a situation in which we have achieved
consensus on both sides of the aisle that striking the FDA and FAA
excuse provisions of the bill is the right thing to do. The managers of
the bill say it is the right thing to do; Senator Dorgan and I, our
three cosponsors say it is the right thing to do; everybody believes
this is a meritorious proposal, one that really will take a positive
step to make this bill a better bill. We have consensus on that. But we
are now stymied by the procedure relating to this legislation.
Now, there are those who say that this legislation has been around
for 14 years now, a long time before I got here or Senator Dorgan got
here or I daresay any number of Senators arrived in this body. This
legislation has very long teeth, indeed, not to mention legs.
But the fact is this is the first time we have been able to raise
this issue of the FDA and FAA excuse, and I think Senator Dorgan and I
have raised it responsibly. I think we have raised it in a way that was
not calculated to make controversy but, rather, to reach consensus. And
were, in fact, able to reach consensus. However, unfortunately, it does
not now appear that we will be able to have a vote on this amendment
before there is a vote on cloture on the underlying bill as a whole. So
this meritorious proposal is being held hostage to the larger questions
relating to this legislation. That is unfortunate, but that is the
legislative process. That is the way things go in the legislative
process. I hope to have the support of my colleagues to vote in support
of the amendment that has been offered by Senator Dorgan and I if we
do, in fact, get a chance to vote on it. If we do get a chance to vote
for it, I hope we are able to make this bill a better bill and a bill
of which this Senate can approve.
I yield.
Mr. DORGAN addressed the Chair.
The PRESIDING OFFICER (Mrs. Murray). The Senator from North Dakota.
Mr. DORGAN. Madam President, I ask for the yeas and nays on this
amendment.
The PRESIDING OFFICER. Is there a sufficient second? There appears to
be a sufficient second.
The yeas and nays were ordered.
Mr. DORGAN. I yield the floor.
Mr. ROCKEFELLER. Will the Senator yield?
Mr. DORGAN. I would be pleased to yield.
The PRESIDING OFFICER. The Senator from West Virginia.
Mr. ROCKEFELLER. Madam President, first of all, I wish to say I know
that the Senator from North Dakota wants to get home, because he has
family obligations, and I do not think we are going to do much more
tonight unless the Senator himself wishes further discussion. I will be
available for so long as people want.
But I would like to repeat what Senator Gorton said, that the FDA/FAA
amendment had a lot of merit. On the other hand, we have not been able
to discuss this bill for 13 years because it has been filibustered by
the same people who are apparently going to filibuster it through
tomorrow and cloture.
Now, if we get cloture, then we will have a vote, and I think if we
have a vote, we will prevail. And we will prevail with a bill, as the
Senator from Illinois has said, that is a much improved bill.
I very strongly, proudly and happily join with the Senator from North
Dakota and the Senator from Illinois in deleting this provision because
I think for the overall public purposes of what we are doing, it does
make it a stronger bill. I would therefore encourage my colleagues, as
they think tonight and tomorrow, that although in the legislative
process filibustering is a useful technique, particularly as used in
the civil rights era, and it has been used from time to time since
then. But this is really a full-fledged filibuster that we are talking
about now. And I think that those who oppose this will simply not stop
talking unless we can get cloture tomorrow. If we can get cloture
tomorrow, I think we can pass a bill which will not have the FDA/FAA
part. And then I will myself say to the Senator from North Dakota and
the Senator from Illinois that it is true the FDA is not perfect, and
it is true that they may not have enough people, and these are things
that now we do not have to worry about because that is no longer a part
of the bill.
So I would urge my colleagues to prayerfully consider their cloture
vote tomorrow, that I hope they would vote for cloture because we now
have a substantially different bill and I think a substantially better
bill. I hope they would consider that, and that when they come to vote
tomorrow they will understand this is a major adjustment in the bill
and that cloture will prevail.
I thank particularly my colleague from North Dakota and also from
Illinois because they have been professional, calm, reasonable, and
just good in the way they have handled this whole situation. I wish to
thank them.
With that, I would yield the floor.
Mr. DORGAN. Madam President, as I understand it, there is an hour of
debate tomorrow morning before the cloture vote, and I think it would
be useful to come back to the subject and continue in some additional
detail on section 203. I know the Senator from Illinois would like to
do that, and I would as well.
I appreciate the comments of the Senator from West Virginia. As he
knows, this is not a new discussion. This discussion occurred the same
day this amendment passed the Senate Commerce Committee, and we are now
some months later at the very point of contention: what about this
section?
I appreciate the likelihood at this point that we may get beyond this
and strip this away. We do have a situation where a cloture vote is
scheduled for 10, and it appears we will not be able to deal with this
amendment before the cloture vote, so we are going to have to discuss
that. But in any event I think we have made some progress for those of
us who believe that this amendment must leave this piece of
legislation, and if it does that we would support advancing the
legislation.
Madam President, I yield the floor.
Mr. HOLLINGS addressed the Chair.
The PRESIDING OFFICER. The Senator from South Carolina.
Mr. HOLLINGS. Let us make the record clear. The distinguished Senator
from Illinois used the proper word this morning, ``masquerade.'' The
masquerade continues.
I intend to vote for the amendment to strike because any time I can
get any section of this bill out; it is that bad, it is that much a
travesty, I am going to support getting it out. But the masquerade does
continue when you come in and say you want uniformity but then put a
sentence that this shall not constitute a Federal cause of action,
sending you to the 50 several jurisdictions--all these words of art
when you talk about in the proof of punitive damage the conscious,
flagrant disregard of safety, and it has to be proved by clear and
convincing. When you say to a seriously injured female under these drug
cases you do not have any economic loss--yes, you can get a small
verdict for the economic loss, but for the pain and suffering and the
noneconomic, we have to get to the proof of several liability on each
one of the several parties--you have given me quite a task of
interrogatories, various discoveries and so on.
Then when you come to settlement, the so-called settlement is a
misnomer if there ever was one because there is an offer made and under
rule 68 a continuing offer made. So the corporate counsel sits up there
and he measures just where he is continually bringing pressure with the
employer of the injured person.
You see, there can be no settlement unless the employer is notified
and joins in. Of course, the insurance company for the manufacturer
gets in touch with that employer, and, says, ``Here is what we will
offer. There is enough money here to take care of your workmen's
compensation, and what you paid for salaries while the injured party
was home sick,'' and otherwise, and, says, ``We can take care of that,
and you had better tell the injured party the sentence so we can get
your money.''
So you bring not only the corporate counsel against you. You bring,
by gosh, the employer against you. Then if you happen to get a little
bit, $1 more, you are in trouble because the $1 more cancels out the
contingency contract. There is a cap on so-called attorney's fees. That
has already been eaten up in the contract itself. The contract itself
was discontinued. But on the other hand, if you get less, I can tell
you here and now what happens. All your collateral benefits are
assessed against your particular verdict, and if you had a health
insurance policy that is taking care of your hospitalization and
medical costs, that is fine business. But that is not what you paid for
to be injured. You are the winner. You have won in the one case and you
proved to all 12 jurors the burden has been on you, and it has been a
clear and convincing burden.
You come around, and even a several burden, and you have done all of
these things after 2 years. Then they take away, let us say $100,000,
and the insurance costs that you put out there. Otherwise, if you had
life insurance, and there is a loss of life involved in the case, I can
tell you exactly what happens. All of that has gone. Of course you have
been paying premiums for 30 or 40 years, like all of us have, to
protect yourself with life insurance, not to become a winner in a
lawsuit and a damage suit. But the winner then becomes the loser.
Because you won, they cancel out all of your insurance benefits. You
have to assess that against your verdict.
So it is nice to be so condescending and tell everybody how wise you
are--and each Senator has his or her own needs.
But I can tell you here and now that will get rid of this
abomination. This bill is calculatedly bad. If they have you down the
side road of the FDA, and still getting this bad bill passed, then we
have not done our job for the injured parties in America here tonight,
or tomorrow morning.
So I want everybody to get to look at the bill in its entirety. It
has been very difficult to discuss the entire measure. I refute the
idea of filibustering. You cannot come in and say we filibuster and
discussed the case but we never discussed the case. I mean, come on.
Which way do you want it? The fact of the matter is we have discussed,
discussed, and discussed again this particular bill in different forms.
It still is what the Chief Justices' Association, every consumer
organization, the attorneys general, legislatures, American Bar
Association, every woman's health group has come out against this
measure.
That is why it has not passed in these years. It has not been the
trial lawyers, and it has not been filibustered. It has been a very,
very bad bill. The States are not coming to Washington and saying
federalize this thing and give us half a haircut with a part
federalized and a part not federalized. They have said leave us alone.
Here is a great moment for those who always wanted to, by gosh, defer
to the States' responsibilities. There is no crisis in litigation
costs, availability of insurance, and otherwise. They come now with
this gimmick. It has been a gimmick. It continues to be one. It is a
bad gimmick. It is a travesty on the injured parties in America.
I hope we can still vote cloture and continue to work against this
bill.
I yield the floor.
Mr. ROCKEFELLER addressed the Chair.
The PRESIDING OFFICER. The Senator from West Virginia.
____________________